Paragraph 26 Insertion of regulation 5(4A)

After regulation 5(4) insert—

“(4A)

In regulation 24 (CE marking of active implantable medical devices)—

(a)

in the heading for “CE marking” substitute “UK marking”;

(b)

for “CE marking” each time those words occur substitute “UK marking”;

(c)

for each reference to “Annex 9” substitute “Annex 2 of Regulation 765/2008”;

(d)

for “notified body” each time those words occur—

(i)

in each of paragraphs (1)(c) and(2)(c);

(ii)

in the words following paragraphs (3)(b) and (4)(b),

substitute “approved body”.”.